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YY/T 0793.1-2022: (Preparation and quality management of fluids for hemodialysis and related treatments - Part 1: Water treatment equipment for hemodialysis and related treatments)
Status: Valid YY/T 0793.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0793.1-2022 | English | 559 |
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(Preparation and quality management of fluids for hemodialysis and related treatments - Part 1: Water treatment equipment for hemodialysis and related treatments)
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YY/T 0793.1-2022
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| YY 0793.1-2010 | English | 599 |
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Technical requirements of water treatment equipments for haemodialysis applications and related therapies. Part 1: For multi-beds haemodialysis
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YY 0793.1-2010
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PDF similar to YY/T 0793.1-2022
Basic data | Standard ID | YY/T 0793.1-2022 (YY/T0793.1-2022) | | Description (Translated English) | (Preparation and quality management of fluids for hemodialysis and related treatments - Part 1: Water treatment equipment for hemodialysis and related treatments) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 30,381 | | Issuing agency(ies) | State Drug Administration | YY 0793.1-2010: Technical requirements of water treatment equipments for haemodialysis applications and related therapies. Part 1: For multi-beds haemodialysis
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Technical requirements of water treatment equipments for haemodialysis applications and related therapies.Part 1. For multi-beds haemodialysis
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Hemodialysis water treatment equipment and related treatment technology
Part 1. For multi-bed dialysis
Part 1. Formulti-bedshaemodialysis
(ISO 26722.2009watertreatmentequipmentsforhaemodialysis
applicationsandrelatedtherapies, NEQ)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
All the technical contents of this standard is mandatory.
Hemodialysis treatment and related water treatment equipment technical standards required standard for the series, the series standard consists of two parts.
--- Part 1. multi-bed for dialysis;
--- Part 2. Single bed for dialysis.
This standard is Part 1 YY 0793 of.
This standard is not equivalent to international standards ISO 26722.2009 hemodialysis treatment and related water treatment equipment (in English).
The different standards with international standards in that.
--- With different names;
--- To limit the scope of the standard to provide a multi-bed hospital hemodialysis water treatment equipment used;
--- Increased "after the temperature compensation device actually treated water is not less than the nominal volume of treated water" requirements and test methods;
--- Added "Electrical Requirements" clause, opt GB 9706.1 according to the electrical system and the degree of isolation of patients' medical electrical equipment
Preparation Part 1. General requirements for safety "or GB 4793.1" measurement, control and laboratory safety of electrical equipment with the requirements of
Part 1. General requirements ";
--- Added "Categories", "working conditions", "inspection rules," "packaging, transport and storage" and other similar terms;
--- Remove the International Standard for Portable water treatment equipment (single bed hemodialysis treatment and related water treatment equipment) correspond
Terms;
--- The treated water in line with the requirements and test methods "ISO 13959" is adjusted to meet the "YY 0572" hemodialysis and related therapies
Water "";
--- The "Material compatibility" has been adjusted to form a "material requirements" clause, the main implementation of GB/T 17219 "in drinking
Security Evaluation Criteria "water equipment and protective materials.
This standard by the National Standardization Technical Committee extracorporeal medical device and focal point responsible for the interpretation.
This standard was drafted. Medical Devices, Institute of Zhejiang Province, the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection
center.
The main drafters of this standard. Lv Weimin, Chen Jia Ye, Huang new Zengfan Feng, Chen Xianming, Liu Yi Qing, Yang Xiaohe, Fan Li Hang.
Hemodialysis water treatment equipment and related treatment technology
Part 1. For multi-bed dialysis
1 Scope
This standard specifies the multi-bed hemodialysis treatment and related water treatment equipment (hereinafter referred to as water treatment equipment) terms and definitions, product
Classification, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage.
This standard applies to the preparation of multi-bed dialysis treatment and related water treatment equipment, does not apply to preparation phase and single bed hemodialysis
Off water treatment water treatment equipment. Water covered include. preparing a powder concentrate with water and dialysate preparation water, dialyzer reuse water.
The standards required range from municipal water treatment equipment (including self-created) drinking water source into the device connection point to the point of use water production equipment
Between all devices, piping and accessories, including. electrical systems, water purification systems, storage and delivery systems and disinfection systems. Not included. concentrate
Liquid supply system, the dialysate regeneration system, dialysis concentrates, hemodiafiltration system, blood filtration system, dialyzer reuse system and peritoneum
Dialysis system.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 191 Packaging - Pictorial signs (GB/T 191-2008, ISO 780.1997, MOD)
GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment Part 1. General requirements (GB 4793.1-
2007, IEC 61010-1.2001, IDT)
GB 5749 drinking water health standards
GB/T 5750.2 drinking water standard test method for water samples collection and preservation
GB/T 5750.10 Standard examination methods for drinking water disinfection by-products index
GB/T 5750.11 Standard examination methods for drinking water disinfectants Index
GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT)
GB/T 9969 General Instructions industrial products
GB/T 13074 Terms of blood purification
GB/T 14710 medical electrical environmental requirements and test methods
GB/T 17219 in drinking water safety equipment and protective materials evaluation criteria
GB/T 18204.27 public places Determination of ozone in air
Determination of GB/T 19108 peracetic acid
YY/T 0466.1 medical equipment used with medical device labels and tags provide information symbols - Part 1. General requirements
(YY 0466.1-2009, ISO 15223-1.2007, IDT)
YY 0572 hemodialysis and related water treatment (YY 0572-2005, ISO 13959.2002, MOD)
3 Terms and Definitions
GB/T 13074 and established the following terms and definitions apply to this standard.
3.1
Chlorine, total chlorine chlorine, total
Total residual chlorine or chlorine
Chemical form chlorine and total chlorine free state.
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